Biohaven Showcases CGRP-Antagonist Franchise Data including Nurtec® ODT (rimegepant), Now Approved to Treat and Prevent Migraine Attacks, and Zavegepant with 19 Presentations at the 2021 Virtual Annual Scientific Meeting of the American Headache Society

Rhea-AI Summary

Biohaven Pharmaceutical Holding Company (NYSE: BHVN) announced its participation in the 63rd Annual Scientific Meeting of the American Headache Society from June 3-6, 2021, showcasing 19 abstracts including a late-breaking presentation on Nurtec ODT (rimegepant). The FDA approved Nurtec ODT for preventive migraine treatment on May 27. Clinical data presented indicate a significant reduction in monthly migraine days and improved quality of life for patients, especially those who failed prior treatments. Additionally, a Phase 2/3 study of intranasal zavegepant demonstrated promising results for acute migraine treatment.

Positive

• Nurtec ODT received FDA approval for preventing episodic migraine on May 27.
• Clinical trials showed a 4.3-day reduction in mean monthly migraine days compared to placebo (p=0.0099).
• Data indicates that rimegepant effectively reduced migraine-related disability in patients with previous treatment failures.
• Health economic analyses suggested decreased monthly tablet usage and better cost-effectiveness compared to alternatives.

Negative

• None.

NEW HAVEN, Conn., June 3, 2021 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today announced that 19 abstracts, including one late-breaking presentation and two oral presentations, will be presented at the virtual 63^rd Annual Scientific Meeting of the American Headache Society (AHS) being held June 3-6. The presentations will be available to view on the AHS website from June 3, 2021 for one year.

Biohaven will be presenting new and encore data presentations for Nurtec ODT (rimegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist in an orally disintegrating tablet (ODT) approved by the FDA for the acute and preventive treatment of migraine in adults. Nurtec ODT received FDA approval for the preventive treatment of episodic migraine in adults on May 27. Efficacy and safety results from the pivotal Phase 2/3 clinical trial of rimegepant for the preventive treatment for migraine will be presented including data showing a rapid reduction in migraine days. Additionally, posters feature data from the Phase 3 trials and the long-term safety study of rimegepant as an acute treatment for migraine, including in people who have a history of treatment failure with triptans. Health economics and outcomes research analyses shed light on the impact of redosing on cost utility outcomes and demonstrate that the use of rimegepant taken as an acute treatment on an as needed basis over one year was associated with a reduction in monthly migraine days and tablet utilization as well as improved quality of life outcomes. An oral presentation for the Phase 2/3 dose-ranging study of intranasal zavegepant, the only intranasal CGRP receptor antagonist currently in late-stage clinical trials for the acute treatment of migraine, will also be presented.

Elyse Stock, MD, Chief Medical Officer of Biohaven commented, "We continue to build on our deep body of research that demonstrates Nurtec ODT's clinical efficacy and safety for the acute and preventive treatment of migraine. We are energized by the recent FDA approval for Nurtec ODT as a preventive treatment for episodic migraine and are excited to bring forward this oral dual therapy indication to physicians and patients alike. The clinical and health economics data presented at AHS emphasize this paradigm changing treatment approach as the first and only medication that can treat and prevent migraine attacks."

Notable highlights include:

• Data from a Phase 2/3 pivotal randomized, placebo-controlled trial assessing rimegepant for the preventive treatment of migraine demonstrated rapid preventive efficacy within the first week of every-other-day dosing, with sustained benefits observed across 12 weeks of double-blind treatment. Rimegepant was superior to placebo on the primary endpoint of change from the observation period in mean monthly migraine days (MMDs) during weeks 9-12 (−4.3 vs −3.5, p=0.0099) as well as on the secondary endpoint of ≥50% reduction in mean number of moderate or severe MMDs during weeks 9-12 (49% vs 41%, p=0.0438).
• Subgroup analyses of triptan failure from the rimegepant clinical trials in the acute treatment of migraine demonstrated treatment with rimegepant up to once daily over one year improved migraine-related disability in subjects who had previously failed 1 or ≥2 triptans and in those who had no history of triptan treatment failure. Additionally, the data shows that rimegepant is effective, well-tolerated, and improves quality of life in those with a history of triptan treatment failure regardless of the number of triptans subjects had previously tried and failed.
• Post-hoc results from an open label safety study of rimegepant demonstrated its preventive benefits when dosed on an as needed basis to treat migraine attacks, expressed as median time to 30% and 50% reduction in monthly migraine days (MMDs). Repeated acute treatment of migraine with rimegepant on an as needed basis achieved clinically relevant reductions in time to 30% and 50% MMDs decrease at 8 weeks and 20 weeks respectively. These findings are consistent with preventive benefits of rimegepant demonstrated in the pivotal Phase 2/3 clinical trial of rimegepant in the preventive treatment of migraine.
• Post-hoc health economics and outcomes research showed that ongoing acute treatment of migraine with rimegepant on an as needed basis over one year of follow-up was found to be associated with reduced monthly migraine days, a corresponding reduction in monthly tablet utilization and did not lend to a trend indicative of medication overuse headache. Additional research also showed that when the impact of re-dosing is considered, rimegepant was associated with more favorable cost-effectiveness results versus usual care compared to ubrogepant and lasmiditan given that in the pivotal trials for these medications redosing was permitted, however this added cost was not incorporated in the recent ICER economic evaluation.
• Data from a Phase 2/3 dose-ranging study of intranasal zavegepant for the acute treatment of migraine show that zavegepant 10 mg and 20 mg demonstrated statistical superiority to placebo on the co-primary endpoints of pain freedom [placebo: 15.5%; 5 mg: 19.6% (p=0.1214); 10 mg: 22.5% (p=0.0113); 20 mg: 23.1% (p=0.0055)] and most bothersome symptom (MBS) freedom [placebo: 33.7%; 5 mg: 39.0% (p=0.1162); 10 mg: 41.9% (p=0.0155); 20 mg: 42.5% (p=0.0094)] at 2 hours post-dose. Rapid onset of pain relief was also observed as early as 15 minutes.

The complete list of accepted abstract titles is below and full presentations will be available on the 2021 AHS virtual annual meeting website beginning June 3, 2021.

Oral Presentations:

• A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant for the Preventive Treatment of Migraine
• Intranasal Zavegepant is Effective and Well Tolerated for the Acute Treatment of Migraine: A Phase 2/3 Dose-Ranging Clinical Trial

Late-Breaking Poster Presentation:

• Effect of Strong P-gp and BCRP Inhibition, Using Cyclosporine and Quinidine as Probes, on the Pharmacokinetics of Oral Rimegepant 75 mg in Healthy Subjects

Poster Presentations:

• Rapid Decrease in Migraine Days with Rimegepant: Results from a Post hoc Analysis of a Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Trial
• Long-term Use of Rimegepant 75 mg for the Acute Treatment of Migraine Reduces Use of Analgesics and Antiemetics
• Rimegepant for the Acute Treatment of Migraine: Subgroup Analyses From 3 Phase 3 Clinical Trials by Number of Triptans Previously Tried and Failed
• An Open-label, Intermediate-size, Expanded Access Protocol of Rimegepant in the Acute Treatment of Migraine
• Rimegepant 75 mg for the Acute Treatment of Migraine in Adults With Frequent Migraine: Long-Term Safety and Clinical Improvement Versus Baseline
• Long-Term Safety of Rimegepant 75 mg for the Acute Treatment of Migraine in Adults With a History of Triptan Treatment Failure
• Acute Treatment with Oral Rimegepant 75 mg Reduces Migraine-Related Disability in Adults With and Without a History of Triptan Treatment Failure: Results from a One Year, Open-Label Safety Study
• Acute Treatment of Migraine With Rimegepant Improves Health Related Quality of Life in Adults With a History of Triptan Treatment Failure: Results from a Long-Term, Open-Label Safety Study
• Preference for Rimegepant and Improved Clinical Global Impression of Change Among Adults With a History of Triptan Treatment Failure: Results from a Long-Term Open-Label Safety Study
• Monthly Migraine Days, Tablet Utilization, and Quality of Life Associated with Rimegepant – Post Hoc Results from an Open Label Safety Study (BHV3000-201)
• Novel Acute Therapies in the Treatment of Migraine: Impact of Re-dosing on Cost-utility Outcomes
• Rimegepant 75 mg, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm
• Identification of High-cost Triptan and Ergotamine-based Acute Therapies used for Migraine in Medicaid 2019
• Acute Treatment with Rimegepant 75 mg Confers Long Term Improvements in Median Time to 30% and 50% Reductions in Monthly Migraine Days – Post Hoc Results from an Open Label Safety Study (BHV3000-201)
• Economic Modeling of Migraine Prevention Therapies: Considerations for Current and Emerging Therapies
• Rimegepant Versus Atogepant and Monoclonal Antibody Treatments for the Prevention of Migraine: A Systematic Literature Review and Network Meta-analysis

About NURTEC ODT
NURTEC ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a quick-dissolve ODT formulation that is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine with or without aura and the preventive treatment of episodic migraine in adults. The activity of the neuropeptide CGRP is thought to play a causal role in migraine pathophysiology. NURTEC ODT is a CGRP receptor antagonist that works by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the CGRP neuropeptide. The recommended dose of NURTEC ODT is 75 mg, taken as needed, up to once daily to treat or every other day to help prevent migraine attacks. For more information about NURTEC ODT, visit www.nurtec.com. The most common adverse reaction was nausea and abdominal pain/indigestion. Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P-gp or BCRP. Avoid another dose of NURTEC ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4.

Indication
NURTEC ODT orally disintegrating tablets is a prescription medicine that is used to treat migraine in adults. It is for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine. It is not known if NURTEC ODT is safe and effective in children.

Important Safety Information
Do not take NURTEC ODT if you are allergic to NURTEC ODT (rimegepant) or any of its ingredients. 

Before you take NURTEC ODT, tell your healthcare provider (HCP) about all your medical conditions, including if you:

• have liver problems,
• have kidney problems,
• are pregnant or plan to become pregnant,
• breastfeeding or plan to breastfeed.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NURTEC ODT may cause serious side effects including allergic reactions, including trouble breathing and rash. This can happen days after you take NURTEC ODT. Call your HCP or get emergency help right away if you have swelling of the face, mouth, tongue, or throat or trouble breathing. This occurred in less than 1% of patients treated with NURTEC ODT.

The most common side effects of NURTEC ODT were nausea (2.7%) and stomach pain/indigestion (2.4%). These are not the only possible side effects of NURTEC ODT. Tell your HCP if you have any side effects.

You are encouraged to report side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch or call 1–800–FDA–1088 or report side effects to Biohaven at 1–833–4NURTEC.

Please click here for full Prescribing Information and Patient Information.

About Zavegepant
Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist from Biohaven's NOJECTION™ Migraine Platform and the only CGRP receptor antagonist in clinical development with both intranasal and oral formulations. The efficacy and safety profile of intranasal zavegepant for the acute treatment of migraine, as compared to placebo, was shown in a randomized controlled Phase 2/3 dose-ranging trial with a total of over 1000 patients who received zavegepant. In this study, zavegepant showed statistical superiority to placebo on the coprimary endpoints of 2 hour freedom from pain and freedom from a patients' most bothersome symptom (either nausea, photophobia or phonophobia). Following successful end of Phase 2 interactions with FDA (clinical and nonclinical), zavegepant is advancing to Phase 3 for the acute treatment of migraine in adults. For more information, visit https://www.biohavenpharma.com/science-pipeline/cgrp/bhv-3500.

About Biohaven
Biohaven is a commercial-stage biopharmaceutical company with a portfolio of innovative, best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven's neuroinnovation™ portfolio includes FDA-approved NURTEC ODT (rimegepant) for the acute treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia; and MPO inhibition for multiple system atrophy and amyotrophic lateral sclerosis. More information about Biohaven is available at www.biohavenpharma.com.

Forward-looking Statement
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including "believe", "may" and "will" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven's management about NURTEC ODT as an acute or preventative treatment for patients with migraine. Forward-looking statements include those related to: Biohaven's ability to effectively commercialize NURTEC ODT, delays or problems in the supply or manufacture of NURTEC ODT, complying with applicable U.S. regulatory requirements, the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, the timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings,  the potential commercialization of Biohaven's product candidates, the potential for Biohaven's product candidates to be first in class or best in class therapies and the effectiveness and safety of Biohaven's product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2021. The forward-looking statements are made as of this date and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

NURTEC and NURTEC ODT are registered trademarks of Biohaven Pharmaceutical Ireland DAC.

Neuroinnovation and NOJECTION are trademarks of Biohaven Pharmaceutical Holding Company Ltd.

Biohaven Contact
Dr. Vlad Coric
Chief Executive Officer
Vlad.Coric@biohavenpharma.com

Media Contact
Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502

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SOURCE Biohaven Pharmaceutical Holding Company Ltd.

FAQ

What is the significance of Nurtec ODT's FDA approval on May 27 for BHVN?

The FDA approval for Nurtec ODT as a preventive treatment for episodic migraine solidifies Biohaven's position in the migraine market and opens new revenue opportunities.

What were the key findings presented at the AHS meeting regarding Nurtec ODT?

Key findings included significant reductions in monthly migraine days and improvements in quality of life metrics for patients treated with Nurtec ODT.

What is the latest clinical data on zavegepant presented at the AHS meeting?

The latest data from the Phase 2/3 study of zavegepant indicated statistical superiority to placebo for acute migraine treatment, demonstrating rapid pain relief.

How does the health economics data impact the perception of rimegepant?

Health economics data suggest rimegepant may offer better cost-effectiveness compared to similar treatments, which could enhance its market appeal.